FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI-LUMEN INTRAVENOUS INFUSION CATH
K Number: K833825
·
Decision Jan 10, 1984
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
6
Review Days
69
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Basic Information
- Device Name
- MULTI-LUMEN INTRAVENOUS INFUSION CATH
- K Number
- K833825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medical Parameters, Inc.
- Date Received
- November 2, 1983
- Decision Date
- January 10, 1984
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Medical Parameters, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862190 | WALRUS: DOUBLE BALLOON SHUNTING CATHETER | Nov 3, 1986 | Substantially Equivalent |
| K844444 | ESOPHAGEAL STETHOSCOPE | Jan 10, 1985 | Substantially Equivalent |
| K830754 | BLOOD PRESSURE MONITORING KITS,WALRUS | Aug 12, 1983 | Substantially Equivalent |
| K831239 | WALRUS PERCUTANEOUS INTRODUCER SET | May 25, 1983 | Substantially Equivalent |
| K830755 | I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- | Apr 28, 1983 | Substantially Equivalent |